User interface with single input for biopsy device

Abstract

A core needle biopsy device includes a needle assembly, a drive assembly, and a user interface. The needle assembly includes a piercer and a hollow cutter. The piercer includes a sharp distal tip and a notch proximal to the distal tip. The piercer is slidably disposed within the cutter to sever a tissue sample into the notch of the piercer. The drive assembly is configured to selectively move the piercer and the cutter. The user interface includes one or more indicators and a single button. The single button is configured to initiate a plurality of movements of the drive assembly to control arming and firing of the piercer and the cutter. The one or more indicators are configured to transition between a plurality of predetermined states to define one or more predetermined status sequences indicative of movement of the piercer and the cutter via the drive assembly.

We claim: 
     
         1 . A core needle biopsy device, comprising:
 (a) a needle assembly, the needle assembly including a piercer and a hollow cutter, the piercer including a sharp distal tip and a notch proximal to the distal tip, the piercer being slidably disposed within the cutter to sever a tissue sample into the notch of the piercer;   (b) a drive assembly configured to selectively move the piercer and the cutter; and   (c) a user interface including one or more indicators and a single button, the single button being configured to initiate a plurality of movements of the drive assembly to control arming and firing of the piercer and the cutter, the one or more indicators being configured to transition between a plurality of predetermined states to define one or more predetermined status sequences indicative of movement of the piercer and the cutter via the drive assembly.   
     
     
         2 . The core needle biopsy device of  claim 1 , the drive assembly being configured to move the piercer and the cutter through an initialization sequence, an arming sequence, a firing sequence, and a sample acquisition sequence, the single button being configured to initiate the initialization sequence, the arming sequence, and the firing sequence using a single button movement associated with each of the initialization sequence, the arming sequence, and the firing sequence. 
     
     
         3 . The core needle biopsy device of  claim 2 , the single button movement associated with each of the initialization sequence, the arming sequence, and the firing sequence being the same for each sequence. 
     
     
         4 . The core needle biopsy device of  claim 2 , one or more of the single button movements associated with each of the initialization sequence, the arming sequence, and the firing sequence being different relative to the other single button movements for at least one of the initialization sequence, the arming sequence, or the firing sequence. 
     
     
         5 . The core needle biopsy device of  claim 2 , the single button movement associated with the firing sequence being a multi-second hold of the single button. 
     
     
         6 . The core needle biopsy device of  claim 2 , the single button movement associated with the firing sequence including a discrete single button movement associated with firing the piercer and firing the cutter. 
     
     
         7 . The core needle biopsy device of  claim 2 , the single button movement associated either the initialization sequence, the arming sequence, and the firing sequence including a double tap of the single button. 
     
     
         8 . The core needle biopsy device of  claim 2 , the single button movement associated either the initialization sequence, the arming sequence, and the firing sequence including a triple tap of the single button. 
     
     
         9 . The core needle biopsy device of  claim 1 , further comprising a controller in communication with the single button and the drive assembly, the controller being configured to receive an input from the single button to drive one or more movements of the drive assembly. 
     
     
         10 . The core needle biopsy device of  claim 9 , the controller being configured to receive a lockout input from the single button, the controller being configured to lock movement of the drive assembly in response to receipt of the lockout input. 
     
     
         11 . The core needle biopsy device of  claim 10 , the lockout input corresponding to the single button being actuated through a predetermined lockout sequence, the predetermined lockout sequence including a long press of 2 or more seconds, a double tap, or a triple tap. 
     
     
         12 . The core needle biopsy device of  claim 9 , the controller being configured to receive a multi-sample input from the single button, the controller being configured to drive a plurality of movements of the drive assembly to collect a plurality of tissue samples sequentially. 
     
     
         13 . The core needle biopsy device of  claim 12 , the multi-sample input from the single button corresponding to a continuous hold of the single button. 
     
     
         14 . The core needle biopsy device of  claim 12 , the multi-sample input from the single button corresponding to a continuous hold of the single button, the controller being configured to drive the plurality of movements of the drive assembly to collect a plurality of tissue samples sequentially during the duration of the continuous hold of the single button and stop the plurality of movements of the drive assembly upon release of the continuous hold of the single button. 
     
     
         15 . A core needle biopsy device, comprising:
 (a) a body;   (b) a needle assembly extending distally from the body, the needle assembly including a piercer and a hollow cutter, the piercer including a sharp distal tip and a notch proximal to the distal tip, the piercer being slidably disposed within the cutter to sever a tissue sample into the notch of the piercer;   (c) a tissue sample holder disposed on a distal end of the body proximate a portion of the needle assembly;   (d) a drive assembly positioned within the body and configured to selectively move the piercer and the cutter; and   (e) a user interface including one or more indicators, a single button, and a controller in communication with the single button and the drive assembly, the single button being disposed on the body proximate the tissue sample holder and transversely centered with respect to a transverse axis of the body, the controller being configured to control one or more movements of the drive assembly using input from the single button, the one or more indicators being configured to transition between a plurality of predetermined states to define one or more predetermined status sequences indicative of movement of the piercer and the cutter via the drive assembly.   
     
     
         16 . The core needle biopsy device of  claim 15 , the single button being disposed proximally of the one or more indicators. 
     
     
         17 . The core needle biopsy device of  claim 15 , the controller being configured to receive a user input from only the single button. 
     
     
         18 . The core needle biopsy device of  claim 15 , the controller being configured to control the drive assembly through a initialization sequence, a arming sequence, a firing sequence, and a sample acquisition sequence, the controller being configured to initiate each of the arming sequence, the firing sequence, and the sample actuation sequence in response to a user input from the single button. 
     
     
         19 . The core needle biopsy device of  claim 18 , the user input from the single button being a long press, a double tap, or a triple tap. 
     
     
         20 . A method for collecting a tissue sample using a biopsy device, the method comprising:
 (a) pressing a single button to initiate arming of the biopsy device, arming the biopsy device including retracting a piercer and a cutter proximally relative to a probe and holster of the biopsy device;   (b) indicating the act of arming using an indicator array by adjusting a plurality of indicators of the indicator array to a predetermined first status sequence;   (c) pressing the single button to initiate firing one or more of the piercer or the cutter;   (d) indicating the act of firing by adjusting the plurality of indicators of the indicator array to a predetermined second status sequence different from the first status sequence;   (e) acquiring a tissue sample using the piercer and the cutter; and   (f) indicating the step of acquiring by adjusting the plurality of indicators of the indicator array to a predetermined third status sequence different from the first and second status sequences.